MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

Model Number 10220

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Electrolyte Imbalance (2196); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/17/2021

Event Type  Injury  

Event Description

The journal article "therapeutic plasma exchange in clinical pediatric neurology practice: experience from a tertiary referral hospital" by yildirim et al 2021 was a retrospective study investigated the efficacy, tolerability, and safety of therapeutic plasma exchange (tpe) in children with neuroimmunological disorders.Twenty three patients (60.9% male, mean age = 9.4 yrs) underwent 186 tpe procedures using spectra optia apheresis system.The mean follow up was 27.1 months.No life-threatening complication occurred.Eight patients experienced complications.During the 186 tpe procedures, 13 complications occurred including hypocalcemia (n=2), hypokalemia (n=2), hypophosphatemia (n=1), anemia (n=3), thrombocytopenia (n=1), hypotension (n=2), mild edema of the eyelids and lips (n=1), and urticaria (n=1).Of the 13 complications, 11 were characterized as mild.During the follow up (mean = 27.1 months; range = 2 to 111 months), 5 patients (21.7%) died.The authors stated that ¿no mortality or long-term morbidity due to tpe occurred.¿ the results are reported in sections 3.3 and 3.6.The authors concluded that ¿tpe was found to be effective in children with various types of neuroimmunological disorder and provided an at least mild improvement in approximately 80% of the patients.Moreover, tpe was well-tolerated without life-threatening complications.The moderate complications were anemia necessitating blood transfusion and urticaria.For this event, one patient with fires: febrile infection-related epilepsy syndrome experienced hypokalemia during the 1st of 7 therapeutic plasma exchange (tpe) procedures performed on this patient.The disease duration prior to tpe was 15 days.The reported improvement with tpe was reported as mild.The patient was reported as mental impairment and seizures after follow-up in 7 months.Patient weight was not provided in the journal article.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.Citation: yildirim, m., bektas, o., botan, e., sahin, s., gurbanov, a., teber, s., & kendirli, t.(2021).Therapeutic plasma exchange in clinical pediatric neurology practice: experience from a tertiary referral hospital.Clinical neurology and neurosurgery, 207, 106823.Https://doi.Org/10.1016/j.Clineuro.2021.106823.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: since this was a journal publication to investigate the efficacy, tolerability, and safety of therapeutic plasma exchange (tpe) in children with neuroimmunological disorders between january 2010 and september 2020, the lot numbers were not requested; therefore, a disposable lot history search or device history record search could not be conducted.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.According to anticoagulation techniques in apheresis: from heparin to citrate and beyond (lee, et al), several metabolic complications other than hypocalcemia have been described with citrate administration including hypomagnesemia, metabolic alkalosis, hypokalemia, and changes in parathyroid hormone levels (pth).These metabolic complications are citrate mediated and often related to citrate infusion rates or donor characteristics.The generation of a metabolic alkalosis contributes to the development of hypokalemia.For example, the simultaneous development of metabolic alkalosis and hypokalemia, with serum potassium levels less than 3.0 meq/l, has been found to occur frequently in patients with ttp after plasma exchange.Metabolic alkalosis directly induces hypokalemia, as high serum bicarbonate levels cause a compensatory shift of hydrogen ions out of the intracellular compartment in exchange for potassium.The concurrent presence of hypocalcemia and hypomagnesemia also contributes to the development of hypokalemia, as the development of citrate-induced hypocalcemia has been found to be strongly associated with the subsequent development of citrate-induced hypokalemia.Citation: yildirim, m., bektas, o., botan, e., sahin, s., gurbanov, a., teber, s., & kendirli, t.(2021).Therapeutic plasma exchange in clinical pediatric neurology practice: experience from a tertiary referral hospital.Clinical neurology and neurosurgery, 207, 106823.Https://doi.Org/10.1016/j.Clineuro.2021.106823 root cause: based on the available information a definitive root cause for the patient reactions could not be determined.A root cause assessment was performed for the hypokalemia and hypophosphatemia.These metabolic complications are citrate mediated and often related to citrate infusion rates or patient characteristics.The generation of a metabolic alkalosis contributes to the development of hypokalemia.For example, the simultaneous development of metabolic alkalosis and hypokalemia, with serum potassium levels less than 3.0 meq/l, has been found to occur frequently in patients with ttp after plasma exchange.Metabolic alkalosis directly induces hypokalemia, as high serum bicarbonate levels cause a compensatory shift of hydrogen ions out of the intracellular compartment in exchange for potassium.The concurrent presence of hypocalcemia and hypomagnesemia also contributes to the development of hypokalemia, as the development of citrate-induced hypocalcemia has been found to be strongly associated with the subsequent development of citrate-induced hypokalemia.

Event Description

The journal article "therapeutic plasma exchange in clinical pediatric neurology practice: experience from a tertiary referral hospital" by yildirim et al 2021 was a retrospective study investigated the efficacy, tolerability, and safety of therapeutic plasma exchange (tpe) in children with neuroimmunological disorders.Twenty three patients (60.9% male, mean age = 9.4 yrs) underwent 186 tpe procedures using spectra optia apheresis system.The mean follow up was 27.1 months.No life-threatening complication occurred.Eight patients experienced complications.During the 186 tpe procedures, 13 complications occurred including hypocalcemia (n=2), hypokalemia (n=2), hypophosphatemia (n=1), anemia (n=3), thrombocytopenia (n=1), hypotension (n=2), mild edema of the eyelids and lips (n=1), and urticaria (n=1).Of the 13 complications, 11 were characterized as mild.During the follow up (mean = 27.1 months; range = 2 to 111 months), 5 patients (21.7%) died.The authors stated that ¿no mortality or long-term morbidity due to tpe occurred.¿ the results are reported in sections 3.3 and 3.6.The authors concluded that ¿tpe was found to be effective in children with various types of neuroimmunological disorder and provided an at least mild improvement in approximately 80% of the patients.Moreover, tpe was well-tolerated without life-threatening complications.The moderate complications were anemia necessitating blood transfusion and urticaria.For this event, one patient with fires: febrile infection-related epilepsy syndrome experienced hypokalemia during the 1st of 7 therapeutic plasma exchange (tpe) procedures performed on this patient.The disease duration prior to tpe was 15 days.The reported improvement with tpe was reported as mild.The patient was reported as mental impairment and seizures after follow-up in 7 months.Patient weight was not provided in the journal article.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 13054045
• MDR Text Key: 282772408
• Report Number: 1722028-2021-00397
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male